Get permission first

Friday, March 28, 2008 | 2:07 a.m.

Hospitals across the country are sterilizing and reusing an increasing number of medical devices labeled as single-use in an effort to control costs and cut the amount of medical waste that ends up in landfills.

The U.S. Food and Drug Administration allows recycling of certain items labeled as single-use, such as scissors, saw blades and scrubs, as long as the FDA’s sterilization and reprocessing guidelines are followed, The Wall Street Journal reported this week.

This recycling of medical devices is different from the unauthorized reuse of unprocessed syringes by a group of Nevada endoscopy centers, which has resulted in the possible exposure of tens of thousands of patients to hepatitis B and C, and HIV.

The FDA allows reprocessing of 100 medical devices, or about 2 percent of all such items labeled as single-use, the Journal reports. The federal rules require that the devices be shipped to approved reprocessing facilities, where they are cleaned, sterilized and tested for efficacy before being shipped.

A January report by the Government Accountability Office, the investigative arm of Congress, said a review of eight years of FDA records suggests there is no evidence that patients face an increased risk of infection from properly reprocessed single-use items.

However, manufacturers of these devices oppose the practice, saying that items labeled as single-use aren’t designed to withstand the stringent sterilization process. They told the Journal that even after sterilization, porous surfaces or crevices can still hold traces of human body fluids or tissue that can carry disease.

Physicians and hospital officials disagree, saying medical device manufacturers have been labeling increasing numbers of their devices as single-use, including saw blades and other items that previously were not labeled as such, as a means of forcing practitioners to buy more products.

Some states are considering legislation that would require doctors and other medical care providers to obtain informed consent from patients before using reprocessed devices. That certainly makes sense to us.

And although single-use medical devices add thousands of tons of trash to landfills each year and increase the cost of health care for everyone, this is an issue that obviously deserves more scrutiny to make sure that doctors and hospitals aren’t unwittingly putting their patients at risk.